Frick Robert, Washburn Brittany, Plocher Dennis, Zoller Jonathan K, Gillihan Jason, Dombrowski Michael, Eby Charles, Farnsworth Christopher W
Department of Pathology & Immunology, Washington University School of Medicine, St. Louis, Missouri, USA.
Department of Laboratories, Barnes Jewish Hospital, St. Louis, Missouri, USA.
Res Pract Thromb Haemost. 2025 Mar 30;9(3):102843. doi: 10.1016/j.rpth.2025.102843. eCollection 2025 Mar.
Viscoelastic testing at point-of-care is associated with reduced blood loss and blood product transfusions. The ROTEM (Werfen) sigma is a cartridge-based system that may facilitate point-of-care use, but limited studies exist comparing the sigma with the predicated ROTEM delta.
We compared the performance of the ROTEM delta with that of the sigma.
Citrated blood was collected from 20 healthy donors and patients during liver transplants ( = 17), obstetrics ( = 15), cardiovascular ( = 9), and trauma surgeries ( = 10). A method comparison was performed using the delta as the predicate. Imprecision was assessed at 2 levels for each assay. Manufacturer reference intervals were verified using 20 healthy donors. An algorithm used for cardiovascular surgery with the delta was compared with the sigma.
The coefficient of variation was <10% for all assays/parameters except for the thromboelastometry with extrinsic activation (EXTEM) clotting time (10.3%) and EXTEM amplitude (A)5 (10.2%). Reference intervals for the delta and sigma were comparable to manufacturer claims. The Pearson r comparing the delta and sigma exceeded .85 for all parameters/assays except for thromboelastometry with cytochalasin D-mediated platelet inhibition (FIBTEM) A10 (.77; 95% CI, .66-.86), FIBTEM A20 (.78; 95% CI, .65-.87), and thromboelastometry with heparinase clotting time (.77; 95% CI, .61-.87). No difference was observed in extrapolated thresholds from the delta-guided algorithm. However, extrapolated sigma A5 parameters for EXTEM were 5 mm lower, and for FIBTEM were 1 mm lower than delta A10 parameters.
The ROTEM delta and sigma devices had comparable performance. A negative bias was observed in the FIBTEM assay with lower extrapolated clinical decision points for a delta-guided treatment algorithm for the FIBTEM and EXTEM A5.
即时护理时的粘弹性测试与减少失血和血液制品输注有关。ROTEM(Werfen)sigma是一种基于试剂盒的系统,可能便于即时护理使用,但将sigma与预测的ROTEM delta进行比较的研究有限。
我们比较了ROTEM delta和sigma的性能。
从20名健康献血者以及肝移植(n = 17)、产科(n = 15)、心血管(n = 9)和创伤手术(n = 10)患者中采集枸橼酸盐抗凝血液。以delta作为参照进行方法比较。对每个检测项目在两个水平评估不精密度。使用20名健康献血者验证制造商的参考区间。将用于心血管手术的delta算法与sigma算法进行比较。
除了外源性激活血栓弹力图(EXTEM)凝血时间(10.3%)和EXTEM振幅(A)5(10.2%)外,所有检测项目/参数的变异系数均<10%。delta和sigma的参考区间与制造商的声明相当。除了细胞松弛素D介导的血小板抑制血栓弹力图(FIBTEM)A10(.77;95%CI,.66-.86)、FIBTEM A20(.78;95%CI,.65-.87)以及肝素酶凝血时间血栓弹力图(.77;95%CI,.61-.87)外,所有参数/检测项目的delta和sigma的Pearson相关系数r均超过.85。在delta引导算法的外推阈值方面未观察到差异。然而,EXTEM的外推sigma A5参数比delta A10参数低5mm,FIBTEM的外推sigma A5参数比delta A10参数低1mm。
ROTEM delta和sigma设备具有相当的性能。在FIBTEM检测中观察到负偏差,对于FIBTEM和EXTEM A5的delta引导治疗算法,其外推临床决策点较低。